Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

AstraZeneca30 enrolled

Overview

The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

AZD4818DRUG

Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days

PlaceboDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of informed consent * Body Mass Index (BMI) between 18.0-27.0 kg/m2 * No clinically relevant abnormal findings Exclusion Criteria: * Acute illness which requires medical intervention * Definite or suspected personal history of adverse drug reactions or drug hypersensitivity. * Clinical relevant disease or disorder (past or present) * A history of respiratory disorders

Locations (1)

Research Site

Osaka, Osaka, Japan

Outcomes

Primary Outcomes

Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry

Time frame: During the study

Lab assessment

Time frame: During the study

Secondary Outcomes

Pharmacokinetics

Time frame: During the study

Data from ClinicalTrials.gov

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